510(k) K981661 ยท KHE Reagent, Occult Blood
HEMAPROMPT
| Applicant | Aerscher Diagnostics, Chestertown MD, US |
| Decision | Substantially Equivalent, Sep 15, 1998 |
| Received | May 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981661
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.